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Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
Subjects will be enrolled in a single-arm study and followed for 1-month after implant of the Neuspera SNM System.
Subjects will complete a questionnaire regarding their experience with the traditional SNM system prior to the Neuspera implant, then undergo an implant of the Neuspera SNM system using standard of care according to the device's commercial labeling.
Up to 20 subjects will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuspera Replacement Cohort | Subjects with previous traditional SNM system and now undergoing implant of the Neuspera SNM System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuspera Implantable Sacral Neuromodulation System | Device | Stimulation of the Sacral Nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Study measure | The changes to subject questionnaire responses for the Neuspera SNM system compared to responses regarding traditional SNM systems | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Study population with 22 years of age or older and who have or have previously had a traditional SNM system.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Vollmer | Contact | 408-433-3839 | mark.vollmer@neuspera.com | |
| Shital Patel | Contact | 3235281320 | shital.patel@neuspera.com |
| Name | Affiliation | Role |
|---|---|---|
| Kellen Choi, DO | University of Louisville Health System | Principal Investigator |
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| Label | URL |
|---|---|
| Neuspera Medical web page | View source |
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |